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Blood Microbiota Signature of Alzheimer's Disease (MICMALZ)

Primary Purpose

Alzheimer Disease, Elderly With Normal Cognition

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Multiomics quantification
Polysomnography
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Alzheimer, Memory, Aging, Microbiota

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

General criteria:

  • Male and/or female;
  • Age between 50-85 years;
  • Having given their free, informed, written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
  • Patient benefiting from a social security scheme

AD group:

  • Diagnosis of Alzheimer's disease according to the international ATN criteria of Albert et al, (1) who had a diagnostic lumbar puncture and CSF biomarker assay and brain imaging with analysis of hippocampal atrophy; topographic and pathophysiological markers must be positive to confirm the etiopathogenic diagnosis;
  • Mild to moderate stage with MMSE score between 10 and 26 ;
  • Symptomatic treatments specific to Alzheimer's disease (acetylcholinesterase inhibitors and memantine) and psychotropic treatments (anxiolytics, antidepressants, neuroleptics) are authorized but must be at fixed doses for more than 3 months ;

Control group:

- Patients seen in memory consultation for concern of having AD but for whom the workup is normal. These patients will have had a diagnostic lumbar puncture during the same memory consultation.

Exclusion Criteria:

Inclusion criteria:

General criteria:

  • Male and/or female;
  • Age between 50-85 years;
  • Having given their free, informed, written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
  • Patient benefiting from a social security scheme

AD group:

  • Diagnosis of Alzheimer's disease according to the international ATN criteria of Albert et al, (1) who had a diagnostic lumbar puncture and CSF biomarker assay and brain imaging with analysis of hippocampal atrophy; topographic and pathophysiological markers must be positive to confirm the etiopathogenic diagnosis;
  • Mild to moderate stage with MMSE score between 10 and 26 ;
  • Symptomatic treatments specific to Alzheimer's disease (acetylcholinesterase inhibitors and memantine) and psychotropic treatments (anxiolytics, antidepressants, neuroleptics) are authorized but must be at fixed doses for more than 3 months ;

Control group:

- Patients seen in memory consultation for concern of having AD but for whom the workup is normal. These patients will have had a diagnostic lumbar puncture during the same memory consultation.

Exclusion criteria:

General criteria:

  • Absence of a family caregiver to complete the neuropsychological scales and questionnaires ;
  • Patient living in a medical institution;
  • Illiteracy or inability to complete the psycho-behavioral tests;
  • Major physical or neurosensory problems likely to interfere with the tests;
  • Contra-indication or refusal to perform the biological tests;
  • Refusal to carry out neuropsychological tests.
  • Refusal of stool collection
  • Digestive neoplasia in progress or < 5 years old
  • Digestive surgery with intestinal resection ;
  • Presence of inflammatory bowel disease or other familial gastrointestinal pathology ;
  • Chronic use of laxatives;
  • Antibiotics taken within one month prior to inclusion;
  • Short-term life-threatening conditions (active cancer, unstable heart failure, severe liver, kidney and respiratory failure);
  • Chronic psychosis or psychotic episodes;
  • Alcohol or drug addiction;
  • Epilepsy and other non-degenerative diseases of the central nervous system
  • Vitamin B12 deficiency and unsupplemented folic acid ;
  • Untreated hypothyroidism;
  • Patient deprived of liberty, by judicial or administrative decision;
  • Major protected by law;
  • Patient in a period of relative exclusion from another protocol;
  • Refusal to participate in the protocol.

AD group :

  • Insufficient clinical and paraclinical information for the diagnosis of AD;
  • Genetic form of AD (known genetic mutation);

Control group: No specific non-inclusion criteria

Sites / Locations

  • Montpellier university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Alzheimer disease group

Control

Neurotypicals

Arm Description

Outcomes

Primary Outcome Measures

Concentration of bacterial 16S rDNA in stools
Concentration of bacterial 16S rDNA in stools

Secondary Outcome Measures

Concentration of bacterial 16s DNA in blood
Concentration of bacterial 16s DNA in blood
Multiomics microbiota signature in AD
Multiomics microbiota signature in AD

Full Information

First Posted
April 8, 2021
Last Updated
April 18, 2023
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT04841135
Brief Title
Blood Microbiota Signature of Alzheimer's Disease
Acronym
MICMALZ
Official Title
Analysis of the Blood Signature of the Microbiota as a Diagnostic Marker of Alzheimer's Disease in the Early Stages of the Process: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 3, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to validate a difference in blood microbial signature between Alzheimer's patients and control subjects in order to propose potential innovative strategies
Detailed Description
This is a pilot study only carried out in Montpellier, aimed at comparing AD patients with control subjects, including men / women aged between 50 and 85 years. The diagnosis of AD patients is based on international criteria. Metagenomics and proteomics will be used to determine the composition of the microbiota in whole blood and stools, but also the metabolomic profile in plasma, stool and the urines.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Elderly With Normal Cognition
Keywords
Alzheimer, Memory, Aging, Microbiota

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer disease group
Arm Type
Other
Arm Title
Control
Arm Type
Other
Arm Title
Neurotypicals
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Multiomics quantification
Intervention Description
One time blood, stool and urine samples will be taken.
Intervention Type
Other
Intervention Name(s)
Polysomnography
Intervention Description
Facultative polysomnography
Primary Outcome Measure Information:
Title
Concentration of bacterial 16S rDNA in stools
Description
Concentration of bacterial 16S rDNA in stools
Time Frame
22 months
Secondary Outcome Measure Information:
Title
Concentration of bacterial 16s DNA in blood
Description
Concentration of bacterial 16s DNA in blood
Time Frame
22 months
Title
Multiomics microbiota signature in AD
Description
Multiomics microbiota signature in AD
Time Frame
22 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: General criteria for AD and control groups: Male and/or female; Age between 50-85 years; Having given their free, informed, written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research); Patient benefiting from a social security scheme AD group: Diagnosis of Alzheimer's disease according to the international ATN criteria of Albert et al, (1) who had a diagnostic lumbar puncture and CSF biomarker assay and brain imaging with analysis of hippocampal atrophy; topographic and pathophysiological markers must be positive to confirm the etiopathogenic diagnosis; Mild to moderate stage with MMSE score between 10 and 26 ; Symptomatic treatments specific to Alzheimer's disease (acetylcholinesterase inhibitors and memantine) and psychotropic treatments (anxiolytics, antidepressants, neuroleptics) are authorized but must be at fixed doses for more than 3 months ; Control group: - Patients seen in memory consultation for concern of having AD but for whom the workup is normal. These patients will have had a diagnostic lumbar puncture during the same memory consultation. Neurotypical group criteria: Male and/or female ; Age between 18-35 years or between 50-85 years; Having given their free, informed, written and signed consent by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research); Patients without cognitive complaints seen in memory consultation but for whom the assessment is normal or young subjects recruited by advertisement. These participants will have an ex-post determination of plasma Aß and tau biomarkers. Exclusion criteria: General criteria for AD and control groups: Absence of a family caregiver to complete the neuropsychological scales and questionnaires ; Patient living in a medical institution; Illiteracy or inability to complete the psycho-behavioral tests; Major physical or neurosensory problems likely to interfere with the tests; Contra-indication or refusal to perform the biological tests; Refusal to carry out neuropsychological tests. Refusal of stool collection Digestive neoplasia in progress or < 5 years old Digestive surgery with intestinal resection ; Presence of inflammatory bowel disease or other familial gastrointestinal pathology ; Chronic use of laxatives; Antibiotics taken within one month prior to inclusion; Short-term life-threatening conditions (active cancer, unstable heart failure, severe liver, kidney and respiratory failure); Chronic psychosis or psychotic episodes; Alcohol or drug addiction; Epilepsy and other non-degenerative diseases of the central nervous system Vitamin B12 deficiency and unsupplemented folic acid ; Untreated hypothyroidism; Patient deprived of liberty, by judicial or administrative decision; Major protected by law; Patient in a period of relative exclusion from another protocol; Refusal to participate in the protocol. AD group : Insufficient clinical and paraclinical information for the diagnosis of AD; Genetic form of AD (known genetic mutation); Control and neurotypical groups: No specific non-inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karim BENNYS, MD, PhD
Phone
+33 4 67 33 72 32
Email
k-bennys@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Sylvie CLAEYSEN
Phone
+33 4 34 35 92 15
Email
sylvie.claeysen@igf.cnrs.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karim BENNYS, MD, PhD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montpellier university hospital
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karim BENNYS, MD, PhD
Phone
+33 4 67 33 72 32
Email
k-bennys@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Sylvie CLAEYSEN
Phone
+33 4 34 35 92 15
Email
sylvie.claeysen@igf.cnrs.fr

12. IPD Sharing Statement

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Blood Microbiota Signature of Alzheimer's Disease

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